Screening for hepatitis C virus infection in a high prevalence country by an antigen/antibody combination assay versus a rapid test

J Virol Methods. 2014 Apr:199:119-23. doi: 10.1016/j.jviromet.2014.01.002. Epub 2014 Jan 30.

Abstract

In low-income-countries, screening for hepatitis C virus (HCV) infection is often based on rapid tests (RT). Their lower sensitivity compared to enzyme immunoassay (EIA) suggests that newer HCV Antigen/Antibody (Ag/Ab) combination assays might have a role in such countries. To test this idea, 1998 blood donors were tested at the University Teaching Hospital blood bank in Yaoundé, Cameroon simultaneously with a RT (HCV rapid test, Human Diagnostics, Berlin, Germany) according to standard practice (S1) and with an Ag/Ab assay (Monolisa HCV Ag/Ab Ultra, Biorad, France) (S2). All discordant, borderline and reactive samples were submitted to confirmatory testing by immunoblot and/or HCV-RNA. Of the 86 (4.3%) samples positive with one or both strategies, 29 were confirmed negative, 37 positive and 20 were false positive or resolved infection. There was a significant difference in test sensitivity (p=0.01) between S1 (70.3%) and S2 (91.9%) but not in test specificity (99.4% and 98.6%, respectively). The benefit of the Ag/Ab assay in the detection of recent HCV seronegative infections could not be evaluated since no Antigen-only donations were identified. However, better Ag/Ab test sensitivity compared to RT supports the implementation of these newer immunoassays for HCV screening in the African blood bank setting.

Keywords: Africa; Ag/Ab combination assay; Blood donors; HCV; Rapid tests.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cameroon
  • Clinical Laboratory Techniques / methods*
  • Diagnostic Tests, Routine / methods*
  • Female
  • Hepatitis C / diagnosis*
  • Hepatitis C / virology
  • Hepatitis C Antibodies / blood*
  • Hepatitis C Antigens / blood*
  • Humans
  • Immunoassay / methods
  • Male
  • Mass Screening / methods*
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Hepatitis C Antibodies
  • Hepatitis C Antigens